Pivoting Annuloplasty Ring Holder for Minimally Invasive Delivery
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Solution Overview
Problem
Current methods for delivering and implanting annuloplasty rings in heart valve surgery are invasive, causing trauma and risk, and are not suitable for less invasive procedures due to rigid handle limitations and difficulties in reshaping handles during surgery.
Innovation Solution
A holder with a pivoting template and remote detachment mechanism, featuring a handle with a pivot mechanism and a ring detachment mechanism using hot wires, blades, or pull wires, allowing for precise orientation and remote detachment of the annuloplasty ring, along with integrated illumination and visualization tools for improved surgical access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a rigid handle is used for delivering annuloplasty ring, then structural stability is improved, but adaptability and ease of reshaping during surgery deteriorate
Solution Approach 1:
The holder assembly incorporates a malleable handle that can be dynamically reshaped during surgery to different angles and configurations. This allows the handle to adapt to various surgical approaches and patient anatomies while maintaining sufficient structural stability to support and control the annuloplasty ring delivery system.
2Adaptability or versatility
If a malleable handle is used for delivering annuloplasty ring, then adaptability is improved, but ease of operation deteriorates due to difficulty in reshaping
Solution Approach 1:
The handle is constructed from materials with specific mechanical properties that allow easy reshaping at body temperature. The material parameters are selected to enable the handle to be bent and shaped during surgery without requiring excessive force, while maintaining the desired shape once formed.
3Ease of operation
If Nitinol material is used for handle, then ease of reshaping is improved, but reliability deteriorates due to shape memory recovery after sterilization
Solution Approach 1:
The holder assembly uses different materials for different components: the handle is made from a malleable material suitable for reshaping, while the template and annuloplasty ring components use rigid materials like stainless steel or titanium for structural integrity. This local differentiation of material properties allows each component to have the optimal characteristics for its specific function.
4Ease of operation
If large incision is made for open-chest surgery, then ease of operation is improved, but object-affected harmful factors worsen due to trauma and risk
Solution Approach 1:
The delivery system is segmented into modular components (handle, template, annuloplasty ring) that can be assembled and manipulated through smaller incisions. The template serves as an intermediate structure that holds the annuloplasty ring in a compressed configuration for delivery through limited access, then expands at the implantation site.
Solution Approach 2:
The annuloplasty ring is nested within or attached to the template structure, which itself is attached to the handle. This nested configuration allows the entire assembly to be delivered through a smaller incision than would be required if the annuloplasty ring had to be passed through separately, reducing surgical trauma while maintaining ease of implantation.
Data Source
AI summary
An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.